Amgen

Sr Associate Quality Control

Employer
Amgen
Location
West Greenwich, RI
Posted
Jun 23, 2022
Ref
R-147035
Discipline
Quality, Quality Control
Required Education
High School or equivalent
Position Type
Full time

HOW MIGHT YOU DEFY IMAGINATION?

Youve earned your degree. How will you use that achievement to reach your goals? Do more with the knowledge youve worked hard to acquire and the passion you already have. At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies, reaching over 10 million patients worldwide. Become the professional you are meant to be in this meaningful role.

Sr Associate Quality Control

Live

What you will do

Lets do this. Lets change the world. In this vital role you will be responsible for activities including microbiological & analytical testing, sample and data management and equipment, instrumentation operation and maintenance, sample and equipment troubleshooting, assistance with reviewing and authorizing documents and samples, and provide leadership on the QC Microbiology team as well as technical/testing support for the QC for MFG testing teams. The staff of the QC Microbiology group perform in a highly dynamic, team environment.

Perform Microbiological testing to support GMP operations across ARI. Perform Microbiological sample and method qualifications including endotoxin, bioburden, microbial identification, qPCR, and other microbiological assays as assigned Support and perform QC laboratory investigations and audits as necessary. Support and document trending analysis, validation protocols/reports, and change controls Perform testing and data review for compendia, non-compendia methods, and routine laboratory procedures. Generate complete, accurate, and concise laboratory documentation using electronic systems, such as LMES, LIMS, and laboratory notebooks. Operate and maintain specialized laboratory equipment and instrumentation. Own and document QC laboratory investigations and audits as necessary. Lead the team to ensure the daily/weekly Level and Flow for testing is performed. Perform general laboratory housekeeping activities and safety inspections Maintain training compliance and proficiency At all times, comply with safety guidelines, cGMPs and other applicable regulatory requirements.

Win

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The knowledgeable professional we seek is a self-motivator with these qualifications.

Basic Qualifications:

  • Masters degree OR
  • Bachelors degree and 2 years of Related experience OR
  • Associates degree and 6 years of Related experience OR
  • High school diploma / GED and 8 years of Related experience

Preferred Qualifications:

  • Professional work experience in a fast-paced, flexible GMP laboratory.
  • Leadership ability, support routine and non-routine testing, method and equipment troubleshooting.
  • Ability to generate, investigate, and close deviations and analytical result assessments in Trackwise (Electronic Database for Capturing Investigations).
  • Ability to generate and document validation protocols and reports. Ability to evaluate data for trends and document corrective actions.
  • Experience performing microbial test methods including but not limited to endotoxin, bioburden, microbial identification, growth promotion, sterility, qPCR, and mycoplasma.
  • Operation, maintenance experience with laboratory equipment.
  • Ability to generate and revise methods and SOPs within CDOCs.
  • Demonstrated proficiency with electronic systems capturing consumables, testing procedures, results, and investigations (LIMS, LMES, CIMS, Trackwise, etc.).
  • Ability to generate, update, and close deviations and analytical result assessments in Trackwise.
  • Demonstrated understanding and use of Maximo (Work order System) Ability to manage and lead Operational Excellence initiatives including Level and Flow, 5S, and Standard Work associated with the testing labs.
  • Demonstrated written and oral communication skills, project management and presentation skills, and proven ability to manage priorities effectively.
  • Demonstrated ability to be flexible and adaptable to support business needs.
Thrive

Some of the vast rewards of working here

As we work to develop treatments that take care of others, we also work to care for our teammates professional and personal growth and well-being.

  • Full support and career-development resources to expand your skills, enhance your expertise, and maximize your potential along your career journey
  • A diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
  • Generous Total Rewards Plancomprising health, finance and wealth, work/life balance, and career benefitswith compensation and benefits rated above 4 stars (out of 5) on Glassdoor
Apply now

for a career that defies imagination

Objects in your future are closer than they appear. Join us.

careers.amgen.com
Join Us

If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.

Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Amgen requires all staff in the United States, Puerto Rico and Canada to be vaccinated from COVID 19 as a condition of employment. In accordance with applicable law, Amgen will provide reasonable accommodations to staff members who qualify on the basis of a medical reason or a sincerely held religious belief, practice, or observance. Such accommodation may not pose an undue hardship to Amgen, its operations, or its staff.